Cuvposa Patent Expiration

Cuvposa is a drug owned by Merz Pharmaceuticals Llc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 20, 2023. Details of Cuvposa's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7638552 Method for increasing the bioavailability of glycopyrrolate
Aug, 2023

(10 months ago)

Expired
US7816396 Method for increasing the bioavailability of glycopyrrolate
Aug, 2023

(10 months ago)

Expired


FDA has granted several exclusivities to Cuvposa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cuvposa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Cuvposa.

Exclusivity Information

Cuvposa holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Cuvposa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jul 28, 2013
Orphan Drug Exclusivity(ODE) Jul 28, 2017

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US patents provide insights into the exclusivity only within the United States, but Cuvposa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Cuvposa's family patents as well as insights into ongoing legal events on those patents.

Cuvposa's family patents


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Generic Launch

Generic Release Date:

Cuvposa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 20, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Cuvposa Generics:

Glycopyrrolate is the generic name for the brand Cuvposa. 41 different companies have already filed for the generic of Cuvposa, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cuvposa's generic

How can I launch a generic of Cuvposa before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Cuvposa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cuvposa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Cuvposa -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1 mg/5 mL 20 Jun, 2012 1 09 Aug, 2021 20 Aug, 2023 Eligible




About Cuvposa

Cuvposa is a drug owned by Merz Pharmaceuticals Llc. It is used for reducing chronic severe drooling in patients with neurologic conditions. Cuvposa uses Glycopyrrolate as an active ingredient. Cuvposa was launched by Merz Pharms in 2010.

Market Authorisation Date:

Cuvposa was approved by FDA for market use on 28 July, 2010.

Active Ingredient:

Cuvposa uses Glycopyrrolate as the active ingredient. Check out other Drugs and Companies using Glycopyrrolate ingredient

Treatment:

Cuvposa is used for reducing chronic severe drooling in patients with neurologic conditions.

Dosage:

Cuvposa is available in solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
1MG/5ML SOLUTION Prescription ORAL